Circaid® Compression Sleeve Versus Short-stretching Bandage in Upper Limb Lymphatic Edema

Launched by CEN BIOTECH · Apr 9, 2018

Keywords

ClinConnect Summary

During the intensive decongestive treatment phase, which usually takes place in specialized lymphedema treatment departments, the staff are properly trained and have the required experience, but the appliance of these short-length compression bandages requires a lot of time. During the maintenance phase, the appliance of short stretch bandages gives way during the day to the wearing of a compression sleeve which can be put on fairly easily. But during the night, in the absence of a nurse or a spouse with the technical skills required to put them in place, few patients can benefit from the w...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • be women over the age of 18;
• • presenting a unilateral lymphedema of the upper limb of stage II or III according to the International Society of Lymphology, secondary to the curative ganglion treatment of a cancer, whatever its nature, and requiring a decongestive treatment by contention / compression;
• • presenting an increase in the volume of the arm affected by lymphedema of at least 10% when compared to the contralateral arm;
• • benefiting of the French health insurance coverage;
• • duly informed of the benefits, constraints and risks of the study;
• • medically and legally able to understand the methods of carrying out the study and to give written informed consent to participate in the study;
• • having given their free written informed consent to their participation in the study
• Exclusion Criteria:
• Not be included in the study:
• * from a medical point of view, the patients:
• • with stage I lymphedema;
• • with lymphedema of multiple locations;
• • having had intensive decongestive treatment in the last 6 months;
• • having a recurrence of cancer or a peripheral arterial disease contraindicating or restraining compression.
• * from a legal point of view, the patients:
• • not in a position to give free and informed consent because of an administrative or judicial decision or a pathology that may affect their judgment or a difficulty of linguistic comprehension;
• • currently participating in another clinical trial or in an exclusion period from another clinical trial;
• • who may not adhere to the terms of the protocol.